Effect of Transcutaneous Auricular Vagal Nerve Stimulation on Chronic Constipation
Study Details
Study Description
Brief Summary
The worldwide prevalence of chronic constipation (CC) is 15%, and women are more likely to develop the disease than men. CC have a significant impact on quality of life and increase the burden of national health insurance. The conventional medication treatments are primarily symptom-specific and have limited efficacy. Previous small sample study had shown the therapeutic potential of transcutaneous auricular vagus nerve stimulation (taVNS) for irritable bowel syndrome with constipation (IBS-C). The aim of this study was to investigate whether taVNS could improve defecation condition and constipation symptoms in patients with CC.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment group patients will receive taVNS at left tragus for four weeks. |
Device: taVNS
Patients will receive taVNS (device produced by Xi'an Bashui Health Technology Co., Ltd) thirty minutes twice a day in the morning and the night for four weeks (duty circle: 30s "on" periods and 30s "off" periods; frequency: 25 Hz; amplitude of 0-2 mA at the maximum level that the patient could tolerate; pulse width: 0.5ms)
Drug: Laxative Agent
Bisacodyl or glycerin enemas can be used in patients who do not have a bowel movement for more than 3 days.
|
| Sham Comparator: Sham-treatment group patients will receive sham-taVNS at left earlobe for four weeks. |
Device: taVNS
Patients will receive taVNS (device produced by Xi'an Bashui Health Technology Co., Ltd) thirty minutes twice a day in the morning and the night for four weeks (duty circle: 30s "on" periods and 30s "off" periods; frequency: 25 Hz; amplitude of 0-2 mA at the maximum level that the patient could tolerate; pulse width: 0.5ms)
Drug: Laxative Agent
Bisacodyl or glycerin enemas can be used in patients who do not have a bowel movement for more than 3 days.
|
Outcome Measures
Primary Outcome Measures
- Responder rate [4 weeks]
Proportion of patients with an average of 3 or more complete spontaneous bowel movements (CSBMs) per week from 1 to 4 weeks
Secondary Outcome Measures
- Responder rate at the time of the follow-up visit [8 weeks]
Proportion of patients with an average of 3 or more CSBMs per week from 5 to 12 weeks
- CSBMs [12 weeks]
Changes from baseline by time point in the CSBMs
- Spontaneous bowel movements (SBMs) [12 weeks]
Changes from baseline by time point in the SBMs
- Abdominal symptoms [12 weeks]
Changes from baseline by time point in abdominal symptoms scores (abdominal bloating, abdominal fullness, abdominal discomfort, abdominal pain, abdominal cramping).
- Bristol stool form scale (BFSF) [12 weeks]
Changes from baseline by time point in the BFSF
- Laxative agents using [12 weeks]
Proportion of patients using laxative agents and/or other adjunctive bowel measures at 1-12 weeks and the average number of times per week
- Patient Assessment of Constipation symptom (PAC-SYM) [12 weeks]
Changes from baseline by time point in the PAC-SYM score
- Patient Assessment of Constipation Quality of Life questionnaire (PAC-QOL) [12 weeks]
Changes from baseline by time point in the PAC-QOL score
- Self-Rating Depression Scale (SDS) [12 weeks]
Changes from baseline by time point in SDS scores
- Self-Rating Anxiety Scale (SAS) [12 weeks]
Changes from baseline by time point in SAS scores
- Adverse events [12 weeks]
Adverse events
Eligibility Criteria
Criteria
Inclusion Criteria:
-
FC or IBS-C patients aged 18-75 years who meet the diagnostic criteria for Rome IV;
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Complete spontaneous bowel movements (CSBMs) per week < 3;
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No constipation medication used for at least 2 weeks prior to enrollment, not participated in clinical trials in the past three months, and no abnormal colonoscopy within the past 12 months in those with alarm symptoms.
Exclusion Criteria:
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Have cognitive impairment, psychiatric disorders, or conditions that may affect patient cooperation;
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Have a cardiac pacemaker implantation or other electronically implanted devices;
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Prior taVNS treatment;
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History of colorectal surgery, except for simple appendectomy;
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Severe cardiovascular, hepatic, or renal disease;
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Known malignancy;
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Secondary constipation caused by medications and other diseases;
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Pregnant or lactating women;
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Refusal to sign an informed consent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Gastroenterology, Second Affiliated Hospital, Lanzhou University | Lanzhou | Gansu | China | 730030 |
| 2 | Department of Gastroenterology, National Clinical Research Center of Infectious Disease, The Third People's Hospital of Shenzhen, The Second Affiliated Hospital of Southern University of Science and Technology | Shenzhen | Guangdong | China | 518114 |
| 3 | Endoscopic center, Xijing Hospital of Digestive Diseases | Xi'an | Shaanxi | China | 710032 |
| 4 | Xijing 986 Hospita | Xi'an | Shaanxi | China | 710032 |
| 5 | Tangdu Hospital | Xi'an | Shaanxi | China | 710038 |
Sponsors and Collaborators
- Air Force Military Medical University, China
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KY20222075-F-1